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Cervicogenic HeadacheNCT04788160

Cervical SNAG Half Rotation Technique in Cervicogenic Headache Patients.

A study testing Cervical SNAGs along with conventional therapy and Conventional Therapy in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to find out the effect of cervical sustained natural apophyseal glide half rotation technique in patients with cervicogenic headache. Not many researches have focused specifically on the cervical sustained natural apophyseal glide half rotation technique and this study intends to see its… Read more about this study

Who is it for?
Ages 25 to 35 years
Conditions the study is for
Cervicogenic Headache
What is being tested?
Cervical SNAGs along with conventional therapy and Conventional Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 sitePakistan
Study dates
13 Aug 2020to 20 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients having experienced headache in the last three months and those with unilateral neck pain.
  • Patients experiencing stiffness are also included along with those exhibiting limited range of motion of neck >10 degree which will be confirmed positive through FRT (flexion-rotation test).

Who cannot join

  • Congenital conditions of the cervical spine
  • Disc herniation patients or fractures in the cervical spine.
  • VBI and associated dizziness
  • Vestibular dysfunctions.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah International University

    Islamabad, Fedral,Pakistan, 440000

Other trials in Pakistan

About this study

Official title: Effects of Cervical SNAG Half Rotation Technique in Cervicogenic Headache Patients.

The purpose of this study is to find out the effect of cervical sustained natural apophyseal glide half rotation technique in patients with cervicogenic headache. Not many researches have focused specifically on the cervical sustained natural apophyseal glide half rotation technique and this study intends to see its effect in the cervicogenic headache patients.

Read the detailed description

Cervicogenic headache is a very frequent complaint that is commonly faced by general population. The International Headache Society placed cervicogenic headache in the secondary headache sub-group. The global prevalence of headache is about 47%, whereas 15% to 20% of those are Cervicogenic headache .Females are four times more prone to Cervicogenic headache than males. Persons with chronic Cervicogenic headache experience significant restriction of everyday function and are limited to social involvement, and emotional sufferings. Beside this, the poorer quality of life is seen in these individuals than normal. Headache can be classified as primary or secondary. Primary headache originates from a vascular or muscular source such as tension-type headache. Secondary headache is related to other structures with cervicogenic headache being the most common type that is related to cervical spine dysfunction. Up to about 70% of frequent intermittent headache are reported with associated neck pain making cervicogenic headache difficult to diagnose.

The C1-C2 segment is considered essential to be examined in Cervicogenic headache diagnosis. Moreover, muscle tightness especially of the upper trapezius and sternocleidomastoid muscles with impaired strength and neuromotor contract of the cervical flexors (superficial and deep) are frequently encountered in subjects with Cervicogenic headache. Different therapeutic approaches have been proposed for treatment of headaches; with physical therapy, pharmacological drugs, and cognitive therapies most commonly used. Several studies reported that manual therapy of the cervical spine can decrease pain intensity, frequency, and duration in addition to reduction in neck pain and disability. The "mobilization with movement" concept, known as the Mulligan concept, is entirely distinct from other forms of manual therapy. Mulligan described the sustained natural apophyseal glide on the joint with active movement done by the patient in the direction of the symptoms. This glide should be pain-free, with proper force applied by a trained person.

The efficacy of sustained natural apophyseal glide C1-C2 has been proven in a research in patients who were experiencing acute to subacute Cervicogenic headache for both short and long-term periods. Mulligan recommended that mobilization should be done towards the restricted site or in the direction of symptom reproduction, which is difficult to find in patients experiencing headache and dizziness in only one direction. There is evidence that mobilizing symptomatic and asymptomatic cervical levels results in immediate improvement of pain and segmental mobility at the same level as well as adjacent areas. sustained natural apophyseal glide Mulligan mobilizations are one of the most popular manual therapy techniques found to be effective in treating Cervicogenic headache as mentioned in the "Neck Pain Guidelines 2017" recommended by American Physical Therapy Association , which reported that patients with neck pain and Cervicogenic headache had significant improvement with self-sustained natural apophyseal glide C1-C2 for both short and long-term periods.

Additionally, sustained natural apophyseal glide as a treatment modality can be applied to all the spinal joints, the rib cage and the sacroiliac joint. They provide a method to improve restricted joint range when symptoms are movement induced. The therapist facilitates the appropriate accessory zygoapophyseal joint glide while the patient performs the symptomatic movement. The facilitatory glide must result in full-range pain-free movement. Sustained end range holds or overpressure can be applied to the physiological movement. This previously symptomatic motion is repeated up to three times while the therapist continues to maintain the appropriate accessory glide. In particular, a cervical sustained natural apophyseal glide is applied with the patient seated, and thus, the spine is in a vertical (i.e. weight bearing or loaded) position.

Mobilization is very effective in the management of Cervicogenic headache. The group of patients who are given sustained natural apophyseal glide showed significantly greater improvement in neck disability index. A research study has shown that the headache sustained natural apophyseal glide is more effective as compared to the reverse headache sustained natural apophyseal glide in the reduction of pain on headache scale. Another research study has shown that C2 sustained natural apophyseal glide and reverse sustained natural apophyseal glide technique were effective in reducing functional disability and headache intensity. Also, C2 sustained natural apophyseal glide was found to be more effective in reducing headache intensity when compared with the other group.

Being tested
Cervical SNAGs along with conventional therapy, Conventional Therapy
Keywords
SNAGs, cervicogenic headache, FRT, NDI, NPRS
Medical subject headings
Post-Traumatic Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervical SNAGs along with conventional therapyOther

    cervical SNAG half rotation technique will be performed with the patient sitting on a chair in the erect posture. The therapist placed his thumb over thumb over the transverse process of C1. Then, he glided ventrally with active rotation of the restricted site 10 times holding for 10 seconds with overpressure at end of the rotation with 30 second rest in between each repetition and 3 session/week for 4 weeks.

    • Conventional therapy will include:
    • Hot pack over the cervical region for 10 minutes.
    • TENS for 10 minutes.
    • Furthermore, general stretching the upper cervical muscles will be done with 5 repetitions with 3 sessions/week for 4 weeks.
    • Isometric cervical extensor exercise with 10 seconds hold for 10 times will be done.
    • Cervical flexor strengthening will be done 10 times in sitting position.
  • Conventional TherapyOther

    • Patients in this group will undergo only conventional therapy which will include:
    • Hot pack for 15 minutes.
    • TENS for 10 minutes.
    • Furthermore, general stretching the upper cervical muscles will be done with 5 repetitions each 3 sessions/week for 4 weeks.
    • Isometric cervical extensor exercise with 10 seconds hold for 10 times will be done.
    • Cervical flexor strengthening will be given to the patient by the therapist, 10 times in sitting position.
Study groups in NCT04788160
Study groupRoleWhat they receive
Cervical SNAGs along with conventional therapyExperimentalpatient will receive Cervical SNAGs along with conventional therapy (Group A)
Receives: Other: Cervical SNAGs along with conventional therapy
Conventional TherapyOtherpatient will receive only conventional therapy (Group B)
Receives: Other: Conventional Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Pain Rating Scale (NPRS)

    This scale will be used for assessing low back pain before and after treatment.0 no pain 1-4 mild pain 5-7 moderate and 8-10 sever pain. Baseline,6th day and 12th day

    Measured: 12th day

  2. Flexion rotation test (FRT)

    The cervical flexion-rotation test (FRT) is used to assist in the diagnosis of CGH and, in particular, C1-C2 segmental dysfunction.Normal range of movement is 44° to each side. The reliability of the test is ICC= 0.7 to 0.75 along with 95% confidence interval

    Measured: 12th day

  3. Neck disability index (NDI)

    gives information about how much neck pain affects the ability to manage everyday life. The reliability of this test in Urdu version is ICC= 0.50 to 0.98

    Measured: 12th day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2021
  2. Study start13 Aug 2020
  3. Primary completion20 Mar 2021
  4. Study completion20 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04788160
Sponsor's protocol ID
REC/00765 Yusra javed
Status last verified
Sep 2021
First submitted
16 Feb 2021
Last updated
20 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Umar M, Naeem A, Badshah M, Zaidi S. A randomized control trial to review the effectiveness of cervical mobilization combined with stretching exercises in cervicogenic headache. J Public Health Biolo Sci. 2012;1(1):09-13.

  • Hall T, Briffa K, Hopper D. Clinical evaluation of cervicogenic headache: a clinical perspective. J Man Manip Ther. 2008;16(2):73-80. doi: 10.1179/106698108790818422.

    PubMed 19119390
  • Petersen SM. Articular and muscular impairments in cervicogenic headache: a case report. J Orthop Sports Phys Ther. 2003 Jan;33(1):21-30; discussion 30-2. doi: 10.2519/jospt.2003.33.1.21.

    PubMed 12570283
  • Islam R, Quddus N, Miraj M, Anwer S. Efficacy of deep cervical flexor strength training versus conventional treatment in cervicogenic headache. Int J Cur Res Rev. 2013;5(08):84-90.

  • Fernandez-de-Las-Penas C, Courtney CA. Clinical reasoning for manual therapy management of tension type and cervicogenic headache. J Man Manip Ther. 2014 Feb;22(1):44-50. doi: 10.1179/2042618613Y.0000000050.

    PubMed 24976747
  • Garcia JD, Arnold S, Tetley K, Voight K, Frank RA. Mobilization and Manipulation of the Cervical Spine in Patients with Cervicogenic Headache: Any Scientific Evidence? Front Neurol. 2016 Mar 21;7:40. doi: 10.3389/fneur.2016.00040. eCollection 2016.

    PubMed 27047446
  • Teys P, Bisset L, Vicenzino B. The initial effects of a Mulligan's mobilization with movement technique on range of movement and pressure pain threshold in pain-limited shoulders. Man Ther. 2008 Feb;13(1):37-42. doi: 10.1016/j.math.2006.07.011. Epub 2006 Oct 27.

    PubMed 17070090
  • Gross A, Kay TM, Paquin JP, Blanchette S, Lalonde P, Christie T, Dupont G, Graham N, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Hoving JL, Bronfort G, Santaguida PL; Cervical Overview Group. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2015 Jan 28;1(1):CD004250. doi: 10.1002/14651858.CD004250.pub5.

    PubMed 25629215
  • Slaven EJ, Goode AP, Coronado RA, Poole C, Hegedus EJ. The relative effectiveness of segment specific level and non-specific level spinal joint mobilization on pain and range of motion: results of a systematic review and meta-analysis. J Man Manip Ther. 2013 Feb;21(1):7-17. doi: 10.1179/2042618612Y.0000000016.

    PubMed 24421608
  • Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.

    PubMed 28666405
  • Wilson E. The Mulligan concept: NAGS, SNAGS and mobilizations with movement. Journal of Bodywork and Movement Therapies. 2001;5(2):81-9.

  • Exelby L. The Mulligan concept: its application in the management of spinal conditions. Man Ther. 2002 May;7(2):64-70. doi: 10.1054/math.2001.0435.

    PubMed 12374089

Questions about this trial

What is this clinical trial studying?

A study testing Cervical SNAGs along with conventional therapy and Conventional Therapy in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Scale (NPRS) (time frame: 12th day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04788160, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.

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